Device Profile Guidelines
Scope: Expert Review articles have been engineered specifically for the online environment. The structure is designed to draw the time-constrained reader directly to the information they require.
Three features in particular contribute to the unique value of Expert Review articles:
- Expert opinion
- Article highlights
- Information resources
Aim: The aim of a Device Profile is to provide a concise review of the design, basic technology, clinical use, and future potential of a specific device. The primary focus of the article should be on the clinical work and post-marketing findings for the device. Using the literature reviewed, the authors are encouraged to provide a critical appraisal of the most important and up-to-date information and discuss how the technology is likely to impact on the clinical management/treatment of specific diseases.
Focus: Authors should restrict their discussion primarily to the specific indication described in the article title but other licensed indications may be discussed as well. It is recommended that national/regional regulatory product guidelines are followed, particularly in terms of indications and dosage. When a device is discussed outside of its approved license, readers should be made aware of this fact in the first instance.
Audience: The audience for the Expert Review series consists of clinicians, research scientists, decision-makers and a range of professionals in the healthcare community. Authors should bear in mind the multidisciplinary status of the readership when writing the article.
Word limit: The word limit for Device Profiles is 2,000-6,000 words (not including tables, figures and references).
Timing: Several factors contribute to the selection of devices and technologies to be reviewed, including scientific need, emergence of new important clinical data, market launches/approval of new indications, and the requirement for an alternative appraisal of the literature. Thus, timing is critical and it is important that the deadlines set by the Commissioning Editor are met. However, if you feel there is a need to delay publication, for instance to discuss new data presented at a scientific meeting or to coincide with the publication of primary literature, the Commissioning Editor will be happy to accommodate such requests.
Every article must contain:
Title: Should be concise but informative, including the device and therapeutic indication.
Authors’ names and addresses: Including address, academic qualifications and job titles of all authors, as well as telephone number, fax number and email address of the author for correspondence on a separate cover sheet as the peer reviewers will be blinded to the authors’ identity. Please note that only the address of the first author of the article will appear on Medline/PubMed, not necessarily the corresponding author.
Structured abstract (maximum 200 words): The aim of the abstract is to draw in the interested reader and provide an accurate reflection of the content of the paper. We therefore request the following structure is followed for full-length review articles:
- Introduction: Authors are required to describe the significance of the topic under discussion.
- Areas covered: Authors are required to describe the research discussed and the literature search undertaken.
- Expert opinion: The author’s expert view on the current status of the field under discussion.
Keywords: A brief list of keywords, in alphabetical order, is required to assist indexers in cross-referencing. The keywords will encompass the therapeutic area, mechanism(s) of action, key components etc.
Introduction: Incorporating basic information on disease incidence and prevalence, unmet medical need and present treatment guidelines (highlighting regional variations where appropriate).
Article highlights: An executive summary of the authors’ main points (bulleted) is very useful for time-constrained readers requiring a rapidly accessible overview.
Body of the review:
Overview of the market
- What are the unmet needs of currently available devices/technologies?
- Specific populations the device may be used for (e.g. elderly, pediatric populations etc.)
Introduction to the device
- How the device works
- Cost-effectiveness (training, waste disposal, equipment required…)
- Performance standards
- Safety and complications
Clinical profile and post-marketing findings
- Data from pre-FDA approval studies
- Data from post-FDA approval studies (if approved)
- Include a table summarizing ongoing and completed clinical trials of the device
- A standalone box, summarizing competing technologies in the field
- Include information on the status of the device, i.e., where it is currently approved, in which countries it is approved and for what indications. Should cover EU, US and rest of the world where appropriate.
- Give the class of the device as determined by the FDA (i.e Class I/II/III)
- A short summary of the data presented in the review.
Expert opinion: To distinguish articles published in the series of journals, authors must provide an additional section entitled Expert opinion. This section affords authors the opportunity to go beyond the conclusion and provide their interpretation of the data presented in the article, discussing any improvements the device has over currently available therapies and how likely physicians are to convert to treatment with the device. In addition, there is the opportunity to discuss the developments that are likely to be important in the future and the avenues of research likely to become exciting as further studies yield more detailed results. Authors are also challenged to include a speculative viewpoint on how the field will have evolved 5 years from the point at which the review was written.
Information resources: A brief summary to direct the reader to the most important further reading, related articles and relevant websites.
Annotated bibliography: Important references should be highlighted with a one/two star system and brief annotations should be given (see the journal Information for Authors page for examples and for a more detailed description of our referencing style).